Clinical Trial Materials for Virus Vaccines

Background and Introduction The National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH) is dedicated to improving global human health through the rigorous pursuit of effective vaccines for human diseases. One of the key components of NIAID's mission involves the rapid advancement of promising vaccine candidates from the laboratory to the clinic. The Division of Intramural Research (DIR) within NIAID has a long history of studying the etiology and pathogenesis of infectious viral diseases, and of developing effective means of preventing or treating these diseases. NIAID DIR has advanced to clinical trials multiple vaccine candidates, including both live-attenuated and inactivated virus formats. These formats have several advantages, including the ability to elicit a strong immune response with only one administration of vaccine. A primary objective of DIR remains the development of safe and effective vaccines against several disease-causing viruses including influenza, respiratory syncytial virus (RSV) and related pediatric respiratory viruses, dengue virus (DENV), and West Nile virus (WNV). In recent years, one of the major areas of DIR's continuing research is the development of live-attenuated vaccine candidates effective against newly identified or emerging viruses, such as Zika virus (ZIKV) or the virus that causes COVID-19 (SARS-CoV-2). The capability to rapidly advance candidates for emerging viruses into clinical testing is now a critical component for NIAID DIR's mission. This acquisition is for a single-award, Indefinite Delivery/Indefinite Quantity (IDIQ) contract that will be funded on a Task Order (TO) basis. The purpose of this acquisition is to establish an appropriate current Good Manufacturing Practice (cGMP) Contract Manufacturing Organization (CMO) to support rapid vaccine development by manufacturing vaccine Clinical Trial Materials (CTM) for trials of live-attenuated virus or inactivated virus vaccine candidates. cGMP is a Food and Drug Administration (FDA) regulation. Vaccine ancillaries or other biologics required to advance to clinical trials, such as virus challenge stocks, diluents, cell lines for use in the production of the vaccines, test materials, etc., are also within scope. The CMO shall have capability to produce viruses in both cell culture and specific-pathogen-free (SPF) eggs at scale appropriate for Phase 1 and 2 clinical trials. Based on extensive history, NIAID has existing processes for manufacturing the virus suspensions (candidate vaccine or challenge stock lot). The Contractor will produce, purify, process, fill, and flash freeze the virus suspensions as directed by NIAID, including any needed process qualifications. All activities required to comply with aseptic cGMP production and product management such as documentation, testing, storage, shipping, stability testing, etc. will also be required as specified under the Statement of Work and associated Task Orders. The contract will support work components in the following areas: Production of Virus Suspensions in Cell Culture Production of Influenza Virus Suspensions in the Allantoic Cavity of Embryonated Eggs Production of Qualified Cell Lines Process Development. Qualification of other vaccine components. For this solicitation, the NIAID requires proposals to be submitted via Online via the NIAID electronic Contract Proposal Submission (eCPS) website. Submission of proposals by facsimile or e-mail is not acceptable. For directions on using eCPS, go to the website https://ecps.nih.gov and then click on "How to Submit." To submit online using eCPS, offerors must have a valid NIH electronic Research Administration (eRA) Commons account, which provides authentication and serves as a vehicle for secure transmission of documents and communication with the NIAID. The eRA Commons registration process may take up to 6 weeks. For more information, please see https://grants.nih.gov/grants/how-to-apply-application-guide/prepare-to-apply-and-register/register.htm Inquiries Please direct all inquiries to: Primary Contact: Mr. Uju Obii-Obioha National Institute of Allergy and Infectious Diseases (NIAID) Telephone: 301-761-6540 Email: uju.obii-obioha@nih.gov. Secondary Contact: Mr. Sevag Kasparian National Institute of Allergy and Infectious Diseases Telephone: 240-669-5177 Email: sevag.kasparian@nih.gov.